Prefrontal iTBS on Working Memory

Sponsor

The Hong Kong Polytechnic University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05774223

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators previous pilot study showed that the brain remained activated after 3 minutes of intermittent theta burst stimulation (iTBS). Therefore, an open question remains that how long the effects will last and when the maximum effects will be achieved. In addition, many pioneering works showed the positive effects of repetitive transcranial magnetic stimulation (rTMS) on working memory. Intermittent theta burst stimulation (iTBS) is a patterned form of rTMS, it has shown a non-inferior efficacy in depression but with a much shorter time (approximately 3 mins) than traditional rTMS (approximately 40 mins).

As discussed above, this study aims to investigate the effects of prefrontal iTBS on working memory using concurrent iTBS/fNIRS and to explore the duration of the effects.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: Transcranial magnetic stimulation (TMS)-active Device: Transcranial magnetic stimulation (TMS)-sham	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Healthy volunteers will receive iTBS two times with active or sham stimulation separated by one week to investigate the effect duration of iTBS on working memoryHealthy volunteers will receive iTBS two times with active or sham stimulation separated by one week to investigate the effect duration of iTBS on working memory

Masking:

Single (Participant)

Masking Description:

Participants will not be informed of the type of stimulation

Primary Purpose:

Basic Science

Official Title:

Exploring the Effects of Prefrontal iTBS on Working Memory in Healthy Participants: a Concurrent TMS/fNIRS Study

Actual Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active iTBS on working memory Participants will receive active 80% rMT iTBS over the left DLPFC in this arm. The working memory assessments will be performed pre-stimulation and at 0-, 10-, 20-, 30-, and 40-min post-stimulation. The working memory assessment is measured using a 2-minute 3-back task. The fNIRS will monitor the prefrontal hemoglobin change throughout the whole procedure.	Device: Transcranial magnetic stimulation (TMS)-active Active intermittent TBS (iTBS) will be applied to the left DLPFC at 80% of the resting motor threshold (rMT) (Hoy et al., 2016). A stimulation, where 3-pulse at 50 Hz will be given, will repeat every 10 s for a total of 190 s (600 pulses in total) (Huang et al., 2005). The left DLPFC stimulation site will be determined using the neuronavigator system (lDLPFC, x-38, y+44, z+26).
Sham Comparator: Sham iTBS on working memory Participants will receive sham 80% rMT iTBS over the left DLPFC (by putting the coil perpendicular to the left DLPFC) in this arm. The working memory assessments will be performed pre-stimulation and at 0-, 10-, 20-, 30-, and 40-min post-stimulation. The working memory assessment is measured using a 2-minute 3-back task. The fNIRS will monitor the prefrontal hemoglobin change throughout the whole procedure.	Device: Transcranial magnetic stimulation (TMS)-sham Sham intermittent TBS (iTBS) will be applied to the left DLPFC at 80% of the resting motor threshold (rMT) (Hoy et al., 2016). The coil will be placed perpendicular to the left DLPFC. A stimulation, where 3-pulse at 50 Hz will be given, will repeat every 10 s for a total of 190 s (600 pulses in total) (Huang et al., 2005). The left DLPFC stimulation site will be determined using the neuronavigator system (lDLPFC, x-38, y+44, z+26).

Arm

Intervention/Treatment

Active Comparator: Active iTBS on working memory

Participants will receive active 80% rMT iTBS over the left DLPFC in this arm. The working memory assessments will be performed pre-stimulation and at 0-, 10-, 20-, 30-, and 40-min post-stimulation. The working memory assessment is measured using a 2-minute 3-back task. The fNIRS will monitor the prefrontal hemoglobin change throughout the whole procedure.

Device: Transcranial magnetic stimulation (TMS)-active

Active intermittent TBS (iTBS) will be applied to the left DLPFC at 80% of the resting motor threshold (rMT) (Hoy et al., 2016). A stimulation, where 3-pulse at 50 Hz will be given, will repeat every 10 s for a total of 190 s (600 pulses in total) (Huang et al., 2005). The left DLPFC stimulation site will be determined using the neuronavigator system (lDLPFC, x-38, y+44, z+26).

Sham Comparator: Sham iTBS on working memory

Participants will receive sham 80% rMT iTBS over the left DLPFC (by putting the coil perpendicular to the left DLPFC) in this arm. The working memory assessments will be performed pre-stimulation and at 0-, 10-, 20-, 30-, and 40-min post-stimulation. The working memory assessment is measured using a 2-minute 3-back task. The fNIRS will monitor the prefrontal hemoglobin change throughout the whole procedure.

Device: Transcranial magnetic stimulation (TMS)-sham

Sham intermittent TBS (iTBS) will be applied to the left DLPFC at 80% of the resting motor threshold (rMT) (Hoy et al., 2016). The coil will be placed perpendicular to the left DLPFC. A stimulation, where 3-pulse at 50 Hz will be given, will repeat every 10 s for a total of 190 s (600 pulses in total) (Huang et al., 2005). The left DLPFC stimulation site will be determined using the neuronavigator system (lDLPFC, x-38, y+44, z+26).

Outcome Measures

Primary Outcome Measures

N-back [before and post iTBS, up to 3 months]
The accuracy number of each n-back task
N-back [before and post iTBS, up to 3 months]
The response time of each n-back task

Secondary Outcome Measures

Hemoglobin change [before and post iTBS, up to 3 months]
The hemoglobin change throughout whole procedure.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

right-handed participants
normal or corrected-to-normal vision

Exclusion Criteria:

a current or past diagnosis of any neurological or psychiatric disorder
any severe medical conditions, seizure, and pregnancy
contraindication to TMS (e.g., with mental implants)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Hong Kong Polytechnic University	Hong Kong		Hong Kong

Sponsors and Collaborators

The Hong Kong Polytechnic University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Georg Kranz, Principal Investigator, The Hong Kong Polytechnic University

ClinicalTrials.gov Identifier:

NCT05774223

Other Study ID Numbers:

HSEARS20200120005-03

First Posted:

Mar 17, 2023

Last Update Posted:

Mar 20, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr Georg Kranz, Principal Investigator, The Hong Kong Polytechnic University

Theta-Burst stimulation (iTBS)

Functional near-infrared spectroscopy (fNIRS)

Concurrent TMS/fNIRS

Working memory

Study Results

No Results Posted as of Mar 20, 2023